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By Rick Weiss
Washington Post Staff Writer
Thursday, March 28, 2002; Page A01

A pharmaceutical company has discovered 70 million to 90 million long-forgotten doses of smallpox vaccine in its freezers, instantly increasing the known U.S. inventory of the vaccine six-fold and ensuring the nation an adequate supply in the event of a bioterrorist attack, according to government sources familiar with the find.

The immediate impact of the discovery is to buy time for the federal government and its pharmaceutical contractors, which together have been racing to produce tens of millions of smallpox vaccine doses as part of the new biodefense initiative. Companies will be able use that cushion of time to fine-tune some of the new vaccine candidates under development, instead of rushing effective but perhaps less-than-perfect vaccines into production as an emergency stopgap measure.

"It's a great insurance policy," said D.A. Henderson, director of the newly created federal Office of Health Preparedness.

The liquid vaccine doses were produced by Aventis Pasteur of Lyon, France, which has its U.S. operations in Swiftwater, Pa. The vaccine has been stored in freezers since it was made decades ago, sources said. It remained unclear yesterday why its existence had gone undiscovered for so long, exactly when it was discovered or by whom.

Sources said the company is negotiating with the Department of Health and Human Services with the goal of giving the U.S. government access to the supply. Among the issues to be worked out are how much money, if any, would change hands in the transaction, and the extent to which the company may be relieved of liability should problems with the vaccine arise.

Calls to Aventis were referred to HHS, which volunteered few details.

"There are legal things that still need to be finalized," said HHS spokesman Bill Hall. HHS Secretary Tommy G. Thompson hopes to settle the deal before next week, Hall said. "Until then, our hands are tied."

A global vaccination effort rid the world of naturally occurring smallpox in 1977, after which the vaccine fell out of production. But a few vials of smallpox viruses were saved in the United States and the Soviet Union. Some experts fear that small amounts of the highly infectious, often fatal agent -- which can be expanded with relative ease in a laboratory -- may have fallen into terrorist hands.

The possibility that smallpox might reemerge as an agent of terror recently inspired U.S. health officials to take stock of existing vaccine supplies. That inventory concluded that the nation has about 15.4 million doses -- barely enough to deal with an attack on a major city or two.

The federal government contracted with various companies to make more of the standard vaccine and to begin work on new and safer versions. But no one knows whether the goal of producing 155 million new doses this year is reachable, and even that would leave the nation far short.

At the same time, in an effort to make more with less, federal scientists have been diluting samples of existing stocks and testing them to see if they are still potent. U.S. health officials have said in recent weeks that studies involving five-fold and ten-fold dilutions are looking very promising. Final results of those tests are to be released today. But even a ten-fold expansion of the previously documented 15.4 million doses would produce only half the doses needed to vaccinate every American.

That shortage is more than covered by the Aventis discovery.

The Aventis vaccine is essentially identical to the previously inventoried vaccine, which was made by Wyeth and went by the name Dryvax. Both were grown from the same seed stock of vaccinia, a virus so similar to the smallpox virus that it primes the immune system against both. The key difference between the two products is that Dryvax is stored as freeze-dried powder, which must be reconstituted by adding a liquid diluent, while the Aventis product was reconstituted and then frozen in its liquid form.

Ongoing studies strongly suggest that the Aventis product is fully potent, according to one government scientist familiar with the work. Indeed, the official said, it's likely that the Aventis product can itself be diluted five-fold if necessary, creating far more doses than would be needed in this nation even in the face of a full-blown bioterrorist attack.

That does not mean it will be easy to defend against such an attack or that deaths would be rare. The vaccine must be given within a few days after exposure to smallpox, posing a logistical nightmare if outbreaks were to occur in several locations simultaneously. Smallpox has historically killed about a third of those it infects.

Another problem is that both the Wyeth and Aventis vaccines can be deadly in people whose immune systems are suppressed by AIDS or other diseases or as a result of their taking drugs for cancer or organ transplantation. In fact, such patients are at risk of life-threatening vaccinia infection simply by coming in contact with others who have been vaccinated, since live viruses are shed from the injection site on the arm.

The discovery of the extra doses could escalate an already heated debate over the wisdom of vaccinating doctors, public health workers and other "first responders," a strategy that some have proposed as a way of ensuring that key personnel would be protected in the event of a covert attack.

One expert yesterday expressed concern that the discovery of the added doses, while reassuring, might lead to a federal decision to offer prophylactic vaccination before a careful analysis of such a program's scientific and social impact is conducted.

"Doing that without proper foresight and planning could be a disaster. It could kill people, that's for certain, and it could undermine the government's credibility," said Tara O'Toole, director of Johns Hopkins' Center for Civilian Biodefense Studies in Baltimore. "There are very significant ethical issues involved in saying, 'Okay, you can have it and you can't.' This is no small challenge."